Text Size

Sleep Enhancement Training Study for Experienced Shiftworkers (SETS-exp)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00786357
First received: November 4, 2008
Last updated: June 22, 2010
Last verified: June 2010
History of Changes
  Purpose

The purpose of this study is to determine if a modified version of the Sleep Enhancement Fatigue Reduction Training (SEFRT) system can improve sleep and health-related symptoms and quality of life in experienced shift-working nurses.


Condition Intervention Phase
Shift-Work Sleep Disorder
 Behavioral: NIOSH shiftwork booklet
Behavioral: Sleep Enhancement Training System
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sleep Enhancement Training Study for Experienced Shiftworkers

Resource links provided by NLM:

MedlinePlus related topics: Sleep Disorders
U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • actigraphy measures of sleep [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • subjective measures of sleep and well-being [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: November 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Behavioral: NIOSH shiftwork booklet
weekly readings about coping with shiftwork
Behavioral: Sleep Enhancement Training System
4 week program of readings and relaxation programs

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English-speaking nurses
  • scheduled to work at least 2 consecutive night shifts per week during the next 3 months
  • ≥40 years of age
  • experiencing disturbed sleep related to night-shift

Exclusion Criteria:

  • current diagnosis of sleep disorder or affective illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786357

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Christopher R. Alsten, PhD Inner Health, Inc.
  More Information

No publications provided

Responsible Party: Christopher Alsten, PhD, Executive Vice President, Inner Health, Inc
ClinicalTrials.gov Identifier: NCT00786357     History of Changes
Other Study ID Numbers: SETS-exp
Study First Received: November 4, 2008
Last Updated: June 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
shift-work
sleep
nurse
relaxation

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Sleep Disorders, Circadian Rhythm
Nervous System Diseases
Neurologic Manifestations
 Signs and Symptoms
Mental Disorders
Chronobiology Disorders
Dyssomnias
Occupational Diseases

ClinicalTrials.gov processed this record on May 23, 2013